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Products contain raw peaches that may be contaminated with Salmonella Enteritidis.
May contain undeclared milk
Undeclared egg.
Trace back information in an outbreak of Salmonella Enteritidis shows peaches from Wawona as likely source of contamination.
undeclared soy (soy milk) allergen
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Product may contain undeclared fish (anchovies), milk and soy.
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.